Elopram

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Elopram uses

Elopram consists of Citalopram Hydrobromide, Citalopram Hydrochloride.

Citalopram Hydrobromide:


Pharmacological action

Elopram is an antidepressant. The mechanism of action is associated with selective blockade of the inverse of neuronal serotonin in the synapses of neurons of the CNS. Elopram (Citalopram Hydrobromide) lacks or has a very weak ability to bind to histamine, m-choline- and adrenoreceptors.

Pharmacokinetics

After oral administration Cmax of Elopram (Citalopram Hydrobromide) in plasma is achieved within 2-4 hours. The oral bioavailability is about 80%. Changes in plasma concentrations of Elopram (Citalopram Hydrobromide) are linear. Css in the plasma is established within 1-2 weeks of therapy.

Binding to plasma proteins is less than 80%.

In blood plasma Elopram (Citalopram Hydrobromide) is present mainly in unchanged form. This drug is metabolized by demethylation, deamination and oxidation.

T1/2 is 1.5 days.

Elopram (Citalopram Hydrobromide) is excreted by the kidneys and the bowel.

Why is Elopram prescribed?

Depression of various etiologies, panic disorder, obsessive-compulsive disorder.

Dosage and administration

Elopram is taken oral 1 time / day.

For adults depending on the evidence the initial dose of Elopram (Citalopram Hydrobromide) is 10-20 mg / day, if necessary, it may be increased up to 60 mg / day. For patients older than 65 years the dose is 20 mg / day, if necessary, it may be increase to 40 mg / day.

Elopram (Citalopram Hydrobromide) side effects, adverse reactions

Digestive system: frequently - dry mouth, nausea.

CNS: frequently - drowsiness, tremor, and in rare cases - seizures (when used in high doses).

Cardiovascular system: possible slight decrease in heart rate.

Other: often - increased sweating.

Adverse reactions are usually transient and weakly expressed. They occur mainly during the first 2 weeks of treatment and usually decrease significantly with the improvement of the patient with depression.

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Elopram contraindications

Hypersensitivity to Elopram (Citalopram Hydrobromide); simultaneous taking MAO inhibitors.

Using during pregnancy and breastfeeding

Safety of Elopram during pregnancy and lactation has not been established. Use of the drug is justified only in cases where the potential benefits of therapy to the mother justifies the potential risk to the fetus and child.

In experimental studies there was revealed no teratogenic effects and any effect of Elopram (Citalopram Hydrobromide) on reproduction and prenatal development of the fetus.

Special instructions

In patients with liver failure Elopram (Citalopram Hydrobromide) should be used in minimal doses.

At weak and moderate renal insufficiency it does not require correction of dosing regimen of Elopram (Citalopram Hydrobromide) Meliapharm, the information on the application in severe renal failure is absent.

During the treatment period with Elopram (Citalopram Hydrobromide) it is possibly a slight decrease in heart rate that has no clinical significance, however, patients with initially reduced heart rate Elopram (Citalopram Hydrobromide) may cause a more pronounced bradycardia.

The efficacy and safety of Elopram (Citalopram Hydrobromide) in children has not been established.

Elopram (Citalopram Hydrobromide) should not be used concurrently with MAO inhibitors.

Patients should be prescribed with care for Elopram (Citalopram Hydrobromide) in highest dose and high doses of cimetidine.

It should be borne in mind that patients with depression are often a decrease in ability to concentrate which can be exacerbated by the use of psychotropic drugs.

Elopram drug interactions

Simultaneous administration of Elopram (Citalopram Hydrobromide) with:

  • MAO inhibitors may develop a hypertensive crisis (serotonin syndrome);
  • cimetidine may moderate increase in Css of Elopram (Citalopram Hydrobromide) in plasmaThe inhibitory effect on CYP2D6 isoenzyme is expressed very poorly, so the interaction with drugs that affect the metabolism of this enzyme is minimal. But we can not exclude the decrease in the concentration of Elopram (Citalopram Hydrobromide) in plasma by increasing its metabolism by carbamazepine induction of liver enzymes in their simultaneous application.

    The effects of sumatriptan and other serotonergic medications can be amplified by Elopram (Citalopram Hydrobromide) in their simultaneous application.

    Elopram in case of emergency / overdose

    Symptoms: dizziness, sweating, nausea, vomiting, tremor, somnolence, sinus tachycardia. In more rare cases - amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis, ECG changes.

    Treatment: gastric lavage and use of activated carbon. Maintaining an airway to ensure adequate ventilation and oxygenation. It is recommended careful observation and monitoring of vital functions. Due to the large volume of distribution of Elopram (Citalopram Hydrobromide) is unlikely efficiency such measures as forced diuresis, dialysis, hemoperfusion and exchange transfusion. There is no specific antidote.

  • Citalopram Hydrochloride:


    Suicidality and Antidepressant Drugs

    Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Elopram (Citalopram Hydrochloride) tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Elopram (Citalopram Hydrochloride) tablets are not approved for use in pediatric patients.

    DESCRIPTION

    Elopram (Citalopram Hydrochloride) HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Elopram (Citalopram Hydrochloride) HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula:

    The molecular formula is C20H22BrFN2O and its molecular weight is 405.35.

    Elopram (Citalopram Hydrochloride) hydrobromide, USP occurs as a fine, white to off-white powder. Elopram (Citalopram Hydrochloride) HBr is sparingly soluble in water and soluble in ethanol.

    Elopram (Citalopram Hydrochloride) hydrobromide, USP is available as tablets.

    Elopram (Citalopram Hydrochloride) hydrobromide, USP 10 mg tablets are film-coated, round tablets containing Elopram (Citalopram Hydrochloride) hydrobromide in strengths equivalent to 10 mg Elopram (Citalopram Hydrochloride) base. Elopram (Citalopram Hydrochloride) hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing Elopram (Citalopram Hydrochloride) hydrobromide in strengths equivalent to 20 mg or 40 mg of Elopram (Citalopram Hydrochloride) base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/ Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white(titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coating agents in the beige (10 mg), pink (20 mg) and white (40 mg) tablets

    Structure

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    CLINICAL PHARMACOLOGY

    Pharmacodynamics

    The mechanism of action of Elopram HBr as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT). In vitro and in vivo studies in animals suggest that Elopram (Citalopram Hydrochloride) is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake. Tolerance to the inhibition of 5-HT uptake is not induced by long-term (14-day) treatment of rats with Elopram (Citalopram Hydrochloride). Elopram (Citalopram Hydrochloride) is a racemic mixture (50/50), and the inhibition of 5-HT reuptake by Elopram (Citalopram Hydrochloride) is primarily due to the (S)-enantiomer.

    Elopram (Citalopram Hydrochloride) has no or very low affinity for 5-HT1A, 5-HT2A, dopamine D1 and D2, (1-, (2-, and (-adrenergic, histamine H1, gamma aminobutyric acid (GABA), muscarinic cholinergic, and benzodiazepine receptors. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of other psychotropic drugs.

    Pharmacokinetics

    The single- and multiple-dose pharmacokinetics of Elopram (Citalopram Hydrochloride) are linear and dose-proportional in a dose range of 10 to 60 mg/day. Biotransformation of Elopram (Citalopram Hydrochloride) is mainly hepatic, with a mean terminal half-life of about 35 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of Elopram (Citalopram Hydrochloride) in plasma, based on the half-life, is expected to be 2.5 times the plasma concentrations observed after a single dose. The tablet and oral solution dosage forms of Elopram (Citalopram Hydrochloride) HBr are bioequivalent.

    Absorption and Distribution

    Following a single oral dose (40 mg tablet) of Elopram (Citalopram Hydrochloride), peak blood levels occur at about 4 hours. The absolute bioavailability of Elopram (Citalopram Hydrochloride) was about 80% relative to an intravenous dose, and absorption is not affected by food. The volume of distribution of Elopram (Citalopram Hydrochloride) is about 12 L/kg and the binding of Elopram (Citalopram Hydrochloride) (CT), demethylcitalopram (DCT) and didemethylcitalopram (DDCT) to human plasma proteins is about 80%.

    Metabolism and Elimination

    Following intravenous administrations of Elopram (Citalopram Hydrochloride), the fraction of drug recovered in the urine as Elopram (Citalopram Hydrochloride) and DCT was about 10% and 5%, respectively. The systemic clearance of Elopram (Citalopram Hydrochloride) was 330 mL/min, with approximately 20% of that due to renal clearance.

    Elopram (Citalopram Hydrochloride) is metabolized to demethylcitalopram (DCT), didemethylcitalopram (DDCT), citalopram-N-oxide, and a deaminated propionic acid derivative. In humans, unchanged Elopram (Citalopram Hydrochloride) is the predominant compound in plasma. At steady state, the concentrations of citalopram's metabolites, DCT and DDCT, in plasma are approximately one-half and one-tenth, respectively, that of the parent drug. In vitro studies show that Elopram (Citalopram Hydrochloride) is at least 8 times more potent than its metabolites in the inhibition of serotonin reuptake, suggesting that the metabolites evaluated do not likely contribute significantly to the antidepressant actions of Elopram (Citalopram Hydrochloride).

    In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes involved in the N-demethylation of Elopram (Citalopram Hydrochloride).

    Population Subgroups

    Age

    Elopram (Citalopram Hydrochloride) pharmacokinetics in subjects ≥ 60 years of age were compared to younger subjects in two normal volunteer studies. In a single-dose study, Elopram (Citalopram Hydrochloride) AUC and half-life were increased in the subjects ≥ 60 years old by 30% and 50%, respectively, whereas in a multiple-dose study they were increased by 23% and 30%, respectively. 20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age (see WARNINGS and DOSAGE AND ADMINISTRATION), due to the risk of QT prolongation.

    Gender

    In three pharmacokinetic studies (total N= 32), Elopram (Citalopram Hydrochloride) AUC in women was one and a half to two times that in men. This difference was not observed in five other pharmacokinetic studies (total N= 114). In clinical studies, no differences in steady state serum Elopram (Citalopram Hydrochloride) levels were seen between men (N= 237) and women (N= 388). There were no gender differences in the pharmacokinetics of DCT and DDCT. No adjustment of dosage on the basis of gender is recommended.

    Reduced hepatic function

    Elopram (Citalopram Hydrochloride) oral clearance was reduced by 37% and half-life was doubled in patients with reduced hepatic function compared to normal subjects. 20 mg/day is the maximum recommended dose for hepatically impaired patients (see WARNINGS and DOSAGE AND ADMINISTRATION), due to the risk of QT prolongation.

    CYP2C19 poor metabolizers

    In CYP2C19 poor metabolizers, Elopram (Citalopram Hydrochloride) steady state Cmax and AUC was increased by 68% and 107%, respectively. Elopram (Citalopram Hydrochloride) 20 mg/day is the maximum recommended dose in CYP2C19 poor metabolizers due to the risk of QT prolongation (see WARNINGS and DOSAGE AND ADMINISTRATION).

    CYP2D6 poor metabolizers

    Elopram (Citalopram Hydrochloride) steady state levels were not significantly different in poor metabolizers and extensive metabolizers of CYP2D6.

    Reduced renal function

    In patients with mild to moderate renal function impairment, oral clearance of Elopram (Citalopram Hydrochloride) was reduced by 17% compared to normal subjects. No adjustment of dosage for such patients is recommended. No information is available about the pharmacokinetics of Elopram (Citalopram Hydrochloride) in patients with severely reduced renal function (creatinine clearance < 20 mL/min).

    Drug Interactions

    In vitro enzyme inhibition data did not reveal an inhibitory effect of Elopram (Citalopram Hydrochloride) on CYP3A4,- 2C9, or -2E1, but did suggest that it is a weak inhibitor of CYP1A2, -2D6, and -2C19. Elopram (Citalopram Hydrochloride) would be expected to have little inhibitory effect on in vivo metabolism mediated by these enzymes. However, in vivo data to address this question are limited.

    CYP3A4 and CYP 2C19 inhibitors: Since CYP3A4 and CYP 2C19 are the primary enzymes involved in the metabolism of Elopram (Citalopram Hydrochloride), it is expected that potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, and macrolide antibiotics) and potent inhibitors of CYP2C19 (e.g., omeprazole) might decrease the clearance of Elopram (Citalopram Hydrochloride). However, coadministration of Elopram (Citalopram Hydrochloride) and the potent CYP3A4 inhibitor ketoconazole did not significantly affect the pharmacokinetics of Elopram (Citalopram Hydrochloride). Elopram (Citalopram Hydrochloride) 20 mg/day is the maximum recommended dose in patients taking concomitant cimetidine or another CYP2C19 inhibitor, because of the risk of QT prolongation (see WARNINGS and DOSAGE AND ADMINISTRATION).

    CYP2D6 Inhibitors

    Coadministration of a drug that inhibits CYP2D6 with Elopram (Citalopram Hydrochloride) is unlikely to have clinically significant effects on Elopram (Citalopram Hydrochloride) metabolism, based on the study results in CYP2D6 poor metabolizers.

    Clinical Efficacy Trials

    The efficacy of Elopram (Citalopram Hydrochloride) as a treatment for depression was established in two placebo-controlled studies (of 4 to 6 weeks in duration) in adult outpatients (ages 18-66) meeting DSM-III or DSM-III-R criteria for major depression. Study 1, a 6-week trial in which patients received fixed Elopram (Citalopram Hydrochloride) doses of 10 mg, 20 mg, 40 mg or 60 mg/day, showed that Elopram (Citalopram Hydrochloride) at doses of 40 and 60 mg/day was effective as measured by the Hamilton Depression Rating Scale (HAMD) total score, the HAMD depressed mood item (Item 1), the Montgomery Asberg Depression Rating Scale, and the Clinical Global Impression (CGI) Severity scale. This study showed no clear effect of the 10 and 20 mg/day doses, and the 60 mg/day dose was not more effective than the 40 mg/day dose. In study 2, a 4-week, placebo-controlled trial in depressed patients, of whom 85% met criteria for melancholia, the initial dose was 20 mg/day, followed by titration to the maximum tolerated dose or a maximum dose of 80 mg/day. Patients treated with Elopram (Citalopram Hydrochloride) showed significantly greater improvement than placebo patients on the HAMD total score, HAMD item 1, and the CGI Severity score. In three additional placebo-controlled depression trials, the difference in response to treatment between patients receiving Elopram (Citalopram Hydrochloride) and patients receiving placebo was not statistically significant, possibly due to high spontaneous response rate, smaller sample size, or, in the case of one study, too low a dose.

    In two long-term studies, depressed patients who had responded to Elopram (Citalopram Hydrochloride) during an initial 6 or 8 weeks of acute treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20 to 60 mg/day in the second study) were randomized to continuation of Elopram (Citalopram Hydrochloride) or to placebo. In both studies, patients receiving continued Elopram (Citalopram Hydrochloride) treatment experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In the fixed-dose study, the decreased rate of depression relapse was similar in patients receiving 20 or 40 mg/day of Elopram (Citalopram Hydrochloride).

    Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics.

    Comparison of Clinical Trial Results

    Highly variable results have been seen in the clinical development of all antidepressant drugs. Furthermore, in those circumstances when the drugs have not been studied in the same controlled clinical trial(s), comparisons among the results of studies evaluating the effectiveness of different antidepressant drug products are inherently unreliable. Because conditions of testing (e.g., patient samples, investigators, doses of the treatments administered and compared, outcome measures, etc.) vary among trials, it is virtually impossible to distinguish a difference in drug effect from a difference due to one of the confounding factors just enumerated.

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    INDICATIONS AND USAGE

    Elopram (Citalopram Hydrochloride) tablets, USP are indicated for the treatment of depression.

    The efficacy of Elopram (Citalopram Hydrochloride) in the treatment of depression was established in 4 to 6 week; controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).

    A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of Elopram (Citalopram Hydrochloride) tablets, USP in hospitalized depressed patients has not been adequately studied.

    The efficacy of Elopram (Citalopram Hydrochloride) in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Elopram (Citalopram Hydrochloride) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

    CONTRAINDICATIONS

    Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS).

    Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

    Elopram (Citalopram Hydrochloride) tablets are contraindicated in patients with a hypersensitivity to Elopram (Citalopram Hydrochloride) or any of the inactive ingredients in Elopram (Citalopram Hydrochloride) tablets.

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    WARNINGS

    WARNINGS-Clinical Worsening and Suicide Risk

    Clinical Worsening and Suicide Risk

    Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

    Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

    The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

    Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
    Increases Compared to Placebo
    < 18 14 additional cases
    18 to 24 5 additional cases
    Decreases Compared to Placebo
    25 to 64 1 fewer case
    ≥ 65 6 fewer cases

    No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

    It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

    All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

    The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

    Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

    If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION- Discontinuation of Treatment with Elopram (Citalopram Hydrochloride) Tablets, USP for a description of the risks of discontinuation of Elopram (Citalopram Hydrochloride) tablets).

    Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Elopram (Citalopram Hydrochloride) tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

    QT-Prolongation and Torsade de Pointes

    Elopram (Citalopram Hydrochloride) causes dose-dependent QTc prolongation, an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of which have been observed in postmarketing reports for Elopram (Citalopram Hydrochloride).

    Individually corrected QTc (QTcNi) interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, escalating multiple-dose study in 119 healthy subjects. The maximum mean (upper bound of the 95% one-sided confidence interval) difference from placebo were 8.5 (10.8) and 18.5 (21) msec for 20 mg and 60 mg Elopram (Citalopram Hydrochloride), respectively. Based on the established exposure-response relationship, the predicted QTcNi change from placebo (upper bound of the 95% one-sided confidence interval) under the Cmax for the dose of 40 mg is 12.6 (14.3) msec.

    Because of the risk of QTc prolongation at higher Elopram (Citalopram Hydrochloride) doses, it is recommended that Elopram (Citalopram Hydrochloride) should not be given at doses above 40 mg/day.

    It is recommended that Elopram (Citalopram Hydrochloride) should not be used in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Elopram (Citalopram Hydrochloride) should also not be used in patients who are taking other drugs that prolong the QTc interval. Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone).

    The Elopram (Citalopram Hydrochloride) dose should be limited in certain populations. The maximum dose should be limited to 20 mg/day in patients who are CYP2C19 poor metabolizers or those patients who may be taking concomitant cimetidine or another CYP2C19 inhibitor, since higher Elopram (Citalopram Hydrochloride) exposures would be expected. The maximum dose should also be limited to 20 mg/day in patients with hepatic impairment and in patients who are greater than 60 years of age because of expected higher exposures.

    Electrolyte and/or ECG monitoring is recommended in certain circumstances. Patients being considered for Elopram (Citalopram Hydrochloride) treatment who are at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurements with periodic monitoring. Hypokalemia (and/or hypomagnesemia) may increase the risk of QTc prolongation and arrhythmia, and should be corrected prior to initiation of treatment and periodically monitored. ECG monitoring is recommended in patients for whom Elopram (Citalopram Hydrochloride) use is not recommended, but, nevertheless, considered essential. These include those patients with the cardiac conditions noted above, and those taking other drugs that may prolong the QTc interval.

    Elopram (Citalopram Hydrochloride) should be discontinued in patients who are found to have persistent QTc measurements >500 ms. If patients taking Elopram (Citalopram Hydrochloride) experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, including cardiac monitoring.

    Screening Patients for Bipolar Disorder

    A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Elopram (Citalopram Hydrochloride) is not approved for use in treating bipolar depression.

    Potential for Interaction with Monoamine Oxidase Inhibitors

    In patients receiving serotonin reuptake inhibitor drugs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Furthermore, limited animal data on the effects of combined use of SSRIs and MAOIs suggest that these drugs may act synergistically to elevate blood pressure and evoke behavioral excitation. Therefore, it is recommended that Elopram (Citalopram Hydrochloride) should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping Elopram (Citalopram Hydrochloride) before starting an MAOI.

    Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

    The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Elopram (Citalopram Hydrochloride) treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.

    The concomitant use of Elopram (Citalopram Hydrochloride) with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Elopram (Citalopram Hydrochloride) with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

    The concomitant use of Elopram (Citalopram Hydrochloride) with serotonin precursors (such as tryptophan) is not recommended. Treatment with Elopram (Citalopram Hydrochloride) and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

    PRECAUTIONS

    General

    Discontinuation of Treatment with Elopram

    During marketing of Elopram (Citalopram Hydrochloride) and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

    Patients should be monitored for these symptoms when discontinuing treatment with Elopram (Citalopram Hydrochloride). A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE AND ADMINISTRATION).

    Abnormal Bleeding

    SSRIs and SNRIs, including Elopram (Citalopram Hydrochloride), may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

    Patients should be cautioned about the risk of bleeding associated with the concomitant use of Elopram (Citalopram Hydrochloride) and NSAIDs, aspirin, or other drugs that affect coagulation

    Hyponatremia

    Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Elopram (Citalopram Hydrochloride). In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), and was reversible when Elopram (Citalopram Hydrochloride) was discontinued. Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk (see Geriatric Use). Discontinuation of Elopram (Citalopram Hydrochloride) should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

    Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.

    Activation of Mania/Hypomania

    In placebo-controlled trials of Elopram (Citalopram Hydrochloride), some of which included patients with bipolar disorder, activation of mania/hypomania was reported in 0.2% of 1063 patients treated with Elopram (Citalopram Hydrochloride) and in none of the 446 patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with other marketed antidepressants. As with all antidepressants, Elopram (Citalopram Hydrochloride) should be used cautiously in patients with a history of mania.

    Seizures

    Although anticonvulsant effects of Elopram (Citalopram Hydrochloride) have been observed in animal studies, Elopram (Citalopram Hydrochloride) has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product's premarketing testing. In clinical trials of Elopram (Citalopram Hydrochloride), seizures occurred in 0.3% of patients treated with Elopram (Citalopram Hydrochloride) (a rate of one patient per 98 years of exposure) and 0.5% of patients treated with placebo (a rate of one patient per 50 years of exposure). Like other antidepressants, Elopram (Citalopram Hydrochloride) should be introduced with care in patients with a history of seizure disorder.

    Interference with Cognitive and Motor Performance

    In studies in normal volunteers, Elopram (Citalopram Hydrochloride) in doses of 40 mg/day did not produce impairment of intellectual function or psychomotor performance. Because any psychoactive drug may impair judgment, thinking, or motor skills, however, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Elopram (Citalopram Hydrochloride) therapy does not affect their ability to engage in such activities.

    Use in Patients with Concomitant Illness

    Clinical experience with Elopram (Citalopram Hydrochloride) in patients with certain concomitant systemic illnesses is limited. Due to the risk of QT prolongation, Elopram (Citalopram Hydrochloride) use should be avoided in patients with certain cardiac conditions, and ECG monitoring is advised if Elopram (Citalopram Hydrochloride) must be used in such patients. Electrolytes should be monitored in treating patients with diseases or conditions that cause hypokalemia or hypomagnesemia. (see WARNINGS).

    In subjects with hepatic impairment, Elopram (Citalopram Hydrochloride) clearance was decreased and plasma concentrations were increased. The use of Elopram (Citalopram Hydrochloride) in hepatically impaired patients should be approached with caution and a lower maximum dosage is recommended (see DOSAGE AND ADMINISTRATION).

    Because Elopram (Citalopram Hydrochloride) is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination. Until adequate numbers of patients with severe renal impairment have been evaluated during chronic treatment with Elopram (Citalopram Hydrochloride), however, it should be used with caution in such patients (see DOSAGE AND ADMINISTRATION).

    Information for Patients

    Physicians are advised to discuss the following issues with patients for whom they prescribe Elopram (Citalopram Hydrochloride).

    Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Elopram (Citalopram Hydrochloride) and triptans, tramadol or other serotonergic agents.

    Although in controlled studies Elopram (Citalopram Hydrochloride) has not been shown to impair psychomotor performance, any psychoactive drug may impair judgment, thinking, or motor skills, so patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Elopram (Citalopram Hydrochloride) therapy does not affect their ability to engage in such activities.

    Patients should be told that, although Elopram (Citalopram Hydrochloride) has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of Elopram (Citalopram Hydrochloride) and alcohol in depressed patients is not advised.

    Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions.

    Patients should be cautioned about the concomitant use of Elopram (Citalopram Hydrochloride) and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding.

    Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

    Patients should be advised to notify their physician if they are breastfeeding an infant. While patients may notice improvement with Elopram (Citalopram Hydrochloride) therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.

    Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Elopram (Citalopram Hydrochloride) and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Elopram (Citalopram Hydrochloride). The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

    Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Elopram (Citalopram Hydrochloride) tablets.

    Clinical Worsening and Suicide Risk

    Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

    Laboratory Tests

    There are no specific laboratory tests recommended.

    Drug Interactions

    Serotonergic Drugs

    Based on the mechanism of action of SNRIs and SSRIs including Elopram, and the potential for serotonin syndrome, caution is advised when Elopram (Citalopram Hydrochloride) is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort (see WARNINGS-Serotonin Syndrome). The concomitant use of Elopram (Citalopram Hydrochloride) with other SSRIs, SNRIs or tryptophan is not recommended (see PRECAUTIONS - Drug Interactions).

    Triptans

    There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Elopram (Citalopram Hydrochloride) with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see WARNINGS - Serotonin Syndrome).

    CNS Drugs

    Given the primary CNS effects of Elopram (Citalopram Hydrochloride), caution should be used when it is taken in combination with other centrally acting drugs.

    Alcohol

    Although Elopram (Citalopram Hydrochloride) did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking Elopram (Citalopram Hydrochloride) is not recommended.

    Monoamine Oxidase Inhibitors (MAOIs) - See CONTRAINDICATIONS and WARNINGS.

    Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)

    Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when citaloram is initiated or discontinued.

    Cimetidine

    In subjects who had received 21 days of 40 mg/day citlaopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in Elopram (Citalopram Hydrochloride) AUC and Cmax of 43% and 39%, respectively.

    Elopram (Citalopram Hydrochloride) 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation (see WARNINGS and DOSAGE AND ADMINISTRATION).

    Digoxin

    In subjects who had received 21 days of 40 mg/day Elopram (Citalopram Hydrochloride), combined administration of Elopram (Citalopram Hydrochloride) and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either Elopram (Citalopram Hydrochloride) or digoxin.

    Lithium

    Coadministration of Elopram (Citalopram Hydrochloride) (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of Elopram (Citalopram Hydrochloride) or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of Elopram (Citalopram Hydrochloride), caution should be exercised when Elopram (Citalopram Hydrochloride) and lithium are coadministered.

    Pimozide

    In a controlled study, a single dose of pimozide 2 mg co-administered with Elopram (Citalopram Hydrochloride) 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Elopram (Citalopram Hydrochloride) did not alter the mean AUC or Cmax of pimozide. The mechanism of this pharmacodynamic interaction is not known.

    Theophylline

    Combined administration of Elopram (Citalopram Hydrochloride) (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of Elopram (Citalopram Hydrochloride) was not evaluated.

    Sumatriptan

    There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, Elopram (Citalopram Hydrochloride)) is clinically warranted, appropriate observation of the patient is advised.

    Warfarin

    Administration of 40 mg/day Elopram (Citalopram Hydrochloride) for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.

    Carbamazepine

    Combined administration of Elopram (Citalopram Hydrochloride) (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough Elopram (Citalopram Hydrochloride) plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of Elopram (Citalopram Hydrochloride) should be considered if the two drugs are coadministered.

    Triazolam

    Combined administration of Elopram (Citalopram Hydrochloride) (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either Elopram (Citalopram Hydrochloride) or triazolam.

    Ketoconazole

    Combined administration of Elopram (Citalopram Hydrochloride) (40 mg) and ketoconazole (200 mg) decreased the Cmax and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of Elopram (Citalopram Hydrochloride).

    CYP2C19 Inhibitors

    Elopram (Citalopram Hydrochloride) 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation (see WARNINGS, DOSAGE AND ADMINISTRATION, and CLINICAL PHARMACOLOGY).

    Metoprolol

    Administration of 40 mg/day citlaopram for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of Elopram (Citalopram Hydrochloride) and metoprolol had no clinically significant effects on blood pressure or heart rate.

    Imipramine and Other Tricyclic Antidepressants (TCAs)

    In vitro studies suggest that Elopram (Citalopram Hydrochloride) is a relatively weak inhibitor of CYP2D6. Coadministration of Elopram (Citalopram Hydrochloride) (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or Elopram (Citalopram Hydrochloride). However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with Elopram (Citalopram Hydrochloride).

    Electroconvulsive Therapy (ECT)

    There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and Elopram (Citalopram Hydrochloride).

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis

    Elopram (Citalopram Hydrochloride) was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of Elopram (Citalopram Hydrochloride) in mice receiving up to 240 mg/kg/day, which is equivalent to 20 times the maximum recommended human daily dose (MRHD) of 60 mg on a surface area (mg/m2) basis. There was an increased incidence of small intestine carcinoma in rats receiving 8 or 24 mg/kg/day, doses which are approximately 1.3 and 4 times the MRHD, respectively, on a mg/m2 basis. A no-effect dose for this finding was not established. The relevance of these findings to humans is unknown.

    Mutagenesis

    Elopram (Citalopram Hydrochloride) was mutagenic in the in vitro bacterial reverse mutation assay (Ames test) in 2 of 5 bacterial strains (Salmonella TA98 and TA1537) in the absence of metabolic activation. It was clastogenic in the in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. Elopram (Citalopram Hydrochloride) was not mutagenic in the in vitro mammalian forward gene mutation assay (HPRT) in mouse lymphoma cells or in a coupled in vitro/in vivo unscheduled DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the in vitro chromosomal aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays.

    Impairment of Fertility

    When Elopram (Citalopram Hydrochloride) was administered orally to 16 male and 24 female rats prior to and throughout mating and gestation at doses of 32 mg, 48 mg, or 72 mg/kg/day, mating was decreased at all doses, and fertility was decreased at doses ≥ 32 mg/kg/day, approximately 5 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. Gestation duration was increased at 48 mg/kg/day, approximately 8 times the MRHD.

    Pregnancy

    Pregnancy Category C

    In animal reproduction studies, Elopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses.

    In two rat embryo/fetal development studies, oral administration of Elopram (Citalopram Hydrochloride) (32 mg, 56 mg, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental, no-effect dose of 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis. Thus, teratogenic effects were observed at a maternally toxic dose in the rat and were not observed in the rabbit.

    When female rats were treated with Elopram (Citalopram Hydrochloride) (4.8 mg, 12.8 mg, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD on a mg/m2 basis. The no-effect dose of 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study.

    There are no adequate and well-controlled studies in pregnant women; therefore, Elopram (Citalopram Hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Pregnancy

    Nonteratogenic Effects

    Neonates exposed to Elopram (Citalopram Hydrochloride) and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS).

    Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective, case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk.

    When treating a pregnant woman with Elopram (Citalopram Hydrochloride) during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION). Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

    Labor and Delivery

    The effect of Elopram on labor and delivery in humans is unknown.

    Nursing Mothers

    As has been found to occur with many other drugs, Elopram (Citalopram Hydrochloride) is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breastfeeding from a citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of Elopram (Citalopram Hydrochloride) by its mother and in the second case, no follow-up information was available. The decision whether to continue or discontinue either nursing or Elopram (Citalopram Hydrochloride) therapy should take into account the risks of Elopram (Citalopram Hydrochloride) exposure for the infant and the benefits of Elopram (Citalopram Hydrochloride) treatment for the mother.

    Pediatric Use

    Safety and effectiveness in the pediatric population have not been established. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with Elopram (Citalopram Hydrochloride), and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of Elopram (Citalopram Hydrochloride) in a child or adolescent must balance the potential risks with the clinical need.

    Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with Elopram (Citalopram Hydrochloride).

    Geriatric Use

    Of 4422 patients in clinical studies of Elopram (Citalopram Hydrochloride), 1357 were 60 and over, 1034 were 65 and over and 457 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Most elderly patients treated with Elopram (Citalopram Hydrochloride) in clinical trials received daily doses between 20 mg and 40 mg (see DOSAGE AND ADMINISTRATION).

    SSRIs and SNRIs, including Elopram (Citalopram Hydrochloride), have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS, Hyponatremia).

    In two pharmacokinetic studies, Elopram (Citalopram Hydrochloride) AUC was increased by 23% and 30%, respectively, in subjects ≥ 60 years of age as compared to younger subjects, and its half-life was increased by 30% and 50%, respectively (see CLINICAL PHARMACOLOGY).

    20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age (see WARNINGS and DOSAGE AND ADMINISTRATION).

    ADVERSE REACTIONS

    The premarketing development program for Elopram (Citalopram Hydrochloride) included Elopram (Citalopram Hydrochloride) exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with Elopram (Citalopram Hydrochloride) varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

    Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

    The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

    Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

    Adverse Events Associated with Discontinuation of Treatment

    Among 1063 depressed patients who received Elopram (Citalopram Hydrochloride) at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e., associated with discontinuation in at least 1% of citalopram-treated patients at a rate at least twice that of placebo) are shown in TABLE 2. It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.

    Percentage of Patients Discontinuing Due to Adverse Event
    Body System/Adverse Event Elopram (Citalopram Hydrochloride) Placebo
    (N = 1063) (N = 446)
    General
    Asthenia 1% < 1%
    Gastrointestinal Disorders
    Nausea 4% 0%
    Dry Mouth 1% < 1%
    Vomiting 1% 0%
    Central and Peripheral Nervous System Disorders
    Dizziness 2% < 1%
    Psychiatric Disorders
    Insomnia 3% 1%
    Somnolence 2% 1%
    Agitation 1% < 1%

    Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients

    Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063 depressed patients who received Elopram (Citalopram Hydrochloride) at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration. Events included are those occurring in 2% or more of patients treated with Elopram (Citalopram Hydrochloride) and for which the incidence in patients treated with Elopram (Citalopram Hydrochloride) was greater than the incidence in placebo-treated patients.

    The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

    The only commonly observed adverse event that occurred in Elopram (Citalopram Hydrochloride) patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients (see TABLE 3).

    (Percentage of Patients Reporting Event)
    Body System/Adverse Event Elopram (Citalopram Hydrochloride) Placebo
    (N = 1063) (N = 446)
    * Events reported by at least 2% of patients treated with Elopram (Citalopram Hydrochloride) are reported, except for the following events which had an incidence on placebo ≥ Elopram (Citalopram Hydrochloride): headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain.
    1 Denominator used was for females only (N = 638 Elopram (Citalopram Hydrochloride); N = 252 placebo).
    2 Primarily ejaculatory delay.
    3 Denominator used was for males only (N = 425 Elopram (Citalopram Hydrochloride); N = 194 placebo).
    Autonomic Nervous System Disorders
    Dry Mouth 20% 14%
    Sweating Increased 11% 9%
    Central & Peripheral Nervous System Disorders
    Tremor 8% 6%
    Gastrointestinal Disorders
    Nausea 21% 14%
    Diarrhea 8% 5%
    Dyspepsia 5% 4%
    Vomiting 4% 3%
    Abdominal Pain 3% 2%
    General
    Fatigue 5% 3%
    Fever 2% < 1%
    Musculoskeletal System Disorders
    Arthralgia 2% 1%
    Myalgia 2% 1%
    Psychiatric Disorders
    Somnolence 18% 10%
    Insomnia 15% 14%
    Anxiety 4% 3%
    Anorexia 4% 2%
    Agitation 3% 1%
    Dysmenorrhea1 3% 2%
    Libido Decreased 2% < 1%
    Yawning 2% < 1%
    Respiratory System Disorders
    Upper Respiratory Tract Infection 5% 4%
    Rhinitis 5% 3%
    Sinusitis 3% < 1%
    Urogenital
    Ejaculation Disorder2,3 6% 1%
    Impotence3 3% < 1%

    Dose Dependency of Adverse Events

    The potential relationship between the dose of Elopram (Citalopram Hydrochloride) administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or Elopram (Citalopram Hydrochloride) 10 mg, 20 mg, 40 mg, or 60 mg. Jonckheere's trend test revealed a positive dose response (p<0.05) for the following adverse events: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning.

    Male and Female Sexual Dysfunction with SSRIs

    Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.

    Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.

    The table below displays the incidence of sexual side effects reported by at least 2% of patients taking Elopram (Citalopram Hydrochloride) in a pool of placebo-controlled clinical trials in patients with depression.

    Treatment Elopram (Citalopram Hydrochloride) Placebo
    Abnormal Ejaculation

    (mostly ejaculatory delay)

    (425 males) (194 males)
    Libido Decreased 6.1% (males only) 1% (males only)
    Impotence 3.8% (males only) < 1% (males only)

    In female depressed patients receiving Elopram (Citalopram Hydrochloride), the reported incidence of decreased libido and anorgasmia was 1.3% (n= 638 females) and 1.1% (n= 252 females), respectively.

    There are no adequately designed studies examining sexual dysfunction with Elopram (Citalopram Hydrochloride) treatment.

    Priapism has been reported with all SSRIs.

    While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

    Vital Sign Changes

    Elopram (Citalopram Hydrochloride) and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Elopram (Citalopram Hydrochloride) treatment. In addition, a comparison of supine and standing vital sign measures for Elopram (Citalopram Hydrochloride) and placebo treatments indicated that Elopram (Citalopram Hydrochloride) treatment is not associated with orthostatic changes.

    Weight Changes

    Patients treated with Elopram (Citalopram Hydrochloride) in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.

    Laboratory Changes

    Elopram (Citalopram Hydrochloride) and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Elopram (Citalopram Hydrochloride) treatment.

    ECG Changes

    In a thorough QT study, Elopram (Citalopram Hydrochloride) was found to be associated with a dose-dependent increase in the QTc interval (see WARNINGS - QT-Prolongation and Torsade de Pointes).

    Electrocardiograms from Elopram (Citalopram Hydrochloride) (N= 802) and placebo (N= 241) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). In the Elopram (Citalopram Hydrochloride) group 1.9% of the patients had a change from baseline in QTcF >60 msec compared to 1.2% of the patients in the placebo group. None of the patients in the placebo group had a post-dose QTcF >500 msec compared to 0.5% of the patients in the Elopram (Citalopram Hydrochloride) group. The incidence of tachycardic outliers was 0.5% in the Elopram (Citalopram Hydrochloride) group and 0.4% in the placebo group. The incidence of bradycardic outliers was 0.9% in the Elopram (Citalopram Hydrochloride) group and 0.4% in the placebo group.

    Other Events Observed During the Premarketing Evaluation of Elopram (Citalopram Hydrochloride) HBr

    Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS section, reported by patients treated with Elopram (Citalopram Hydrochloride) at multiple doses in a range of 10 to 80 mg/day during any phase of a trial within the premarketing database of 4422 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those occurring in only one patient. It is important to emphasize that, although the events reported occurred during treatment with Elopram (Citalopram Hydrochloride), they were not necessarily caused by it.

    Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

    Cardiovascular -Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema (extremities), angina pec toris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.

    Central and Peripheral Nervous System Disorders -Frequent: paresthesia, migraine. Infrequent: hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia. Rare: abnormal coordination, hyperesthesia, ptosis, stupor.

    Endocrine Disorders -Rare: hypothyroidism, goiter, gynecomastia.

    Gastrointestinal Disorders -Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.

    General -Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hayfever.

    Hemic and Lymphatic Disorders -Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.

    Metabolic and Nutritional Disorders -Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.

    Musculoskeletal System Disorders -Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis.

    Psychiatric Disorders -Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, confusion. Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia.

    Reproductive Disorders/Female* -Frequent: amenorrhea. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage.

    *% based on female subjects only: 2955

    Respiratory System Disorders -Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia. Rare: asthma, laryngitis, bronchospasm, pneumonitis, sputum increased.

    Skin and Appendages Disorders -Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, psoriasis. Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.

    Special Senses -Frequent: accommodation abnormal, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, taste loss.

    Urinary System Disorders -Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.

    Other Events Observed During the Postmarketing Evaluation of Elopram (Citalopram Hydrochloride) HBr

    It is estimated that over 30 million patients have been treated with Elopram (Citalopram Hydrochloride) since market introduction. Although no causal relationship to Elopram (Citalopram Hydrochloride) treatment has been found, the following adverse events have been reported to be temporally associated with Elopram (Citalopram Hydrochloride) treatment, and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, glaucoma, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal syndrome.

    DRUG ABUSE AND DEPENDENCE

    Controlled Substance

    Elopram HBr is not a controlled substance.

    Physical and Psychological Dependence

    Animal studies suggest that the abuse liability of Elopram (Citalopram Hydrochloride) is low. Elopram (Citalopram Hydrochloride) has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with Elopram (Citalopram Hydrochloride) did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Elopram (Citalopram Hydrochloride) patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

    OVERDOSAGE

    Human Experience

    In clinical trials of Elopram (Citalopram Hydrochloride), there were reports of Elopram (Citalopram Hydrochloride) overdose, including overdoses of up to 2000mg, with no associated fatalities. During the postmarketing evaluation of Elopram (Citalopram Hydrochloride), Elopram (Citalopram Hydrochloride) overdoses, including overdoses of up to 6000 mg, have been reported. As with other SSRIs, a fatal outcome in a patient who has taken an overdose of Elopram (Citalopram Hydrochloride) has been rarely reported.

    Symptoms most often accompanying Elopram (Citalopram Hydrochloride) overdose, alone or in combination with other drugs and/or alcohol, included dizziness, sweating, nausea, vomiting, tremor, somnolence, and sinus tachycardia. In more rare cases, observed symptoms included amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis, and ECG changes (including QTc prolongation, nodal rhythm, ventricular arrhythmia, and very rare cases of torsade de pointes). Acute renal failure has been very rarely reported accompanying overdose.

    Management of Overdose

    Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of Elopram (Citalopram Hydrochloride), forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for Elopram (Citalopram Hydrochloride). In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

    DOSAGE AND ADMINISTRATION

    Elopram (Citalopram Hydrochloride) tablets, USP should be administered once daily, in the morning or evening, with or without food.

    Initial Treatment

    Elopram (Citalopram Hydrochloride) tablets, USP should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

    Special Populations

    20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see WARNINGS)

    No dosage adjustment is necessary for patients with mild or moderate renal impairment. Elopram (Citalopram Hydrochloride) should be used with caution in patients with severe renal impairment.

    Treatment of Pregnant Women During the Third Trimester

    Neonates exposed to Elopram (Citalopram Hydrochloride) and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Elopram (Citalopram Hydrochloride) tablets, USP during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Elopram (Citalopram Hydrochloride) tablets, USP in the third trimester.

    Maintenance Treatment

    It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Elopram (Citalopram Hydrochloride) in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Elopram (Citalopram Hydrochloride) (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Elopram (Citalopram Hydrochloride) 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of Elopram (Citalopram Hydrochloride) needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

    Discontinuation of Treatment with Elopram (Citalopram Hydrochloride) tablets, USP

    Symptoms associated with discontinuation of Elopram (Citalopram Hydrochloride) and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

    Switching Patients To or From a Monoamine Oxidase Inhibitor

    At least 14 days should elapse between discontinuation of an MAOI and initiation of Elopram (Citalopram Hydrochloride) therapy. Similarly, at least 14 days should be allowed after stopping Elopram (Citalopram Hydrochloride) before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

    HOW SUPPLIED

    Elopram (Citalopram Hydrochloride) Tablets, USP

    10 mg. They are supplied in

    Beige, film coated round, bi-convex tablets de-bossed with IG on one side and “206” on the other.

    20 mg. They are supplied in

    Pink, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “207” on the other.

    40 mg. They are supplied in

    White, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “208” on the other.

    Store at 20°C to 25°C (68°F to 77°F)

    ANIMAL TOXICOLOGY

    Retinal Changes in Rats

    Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with Elopram (Citalopram Hydrochloride). There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day (13 times the maximum recommended daily human dose of 60 mg on a mg/m2 basis). Similar findings were not present in rats receiving 24 mg/kg/day for two years, in mice treated for 18 months at doses up to 240 mg/kg/day, or in dogs treated for one year at doses up to 20 mg/kg/day (4, 20, and 10 times, respectively, the maximum recommended daily human dose on a mg/m2 basis).

    Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established.

    Cardiovascular Changes in Dogs

    In a one-year toxicology study, 5 of 10 beagle dogs receiving oral doses of 8 mg/kg/day (4 times the maximum recommended daily human dose of 60 mg on a mg/m2 basis) died suddenly between weeks 17 and 31 following initiation of treatment. Although appropriate data from that study are not available to directly compare plasma levels of Elopram (Citalopram Hydrochloride) (CT) and its metabolites, demethylcitalopram (DCT) and didemethylcitalopram (DDCT), to levels that have been achieved in humans, pharmacokinetic data indicate that the relative dog-to-human exposure was greater for the metabolites than for Elopram (Citalopram Hydrochloride). Sudden deaths were not observed in rats at doses up to 120 mg/kg/day, which produced plasma levels of CT, DCT, and DDCT similar to those observed in dogs at doses of 8 mg/kg/day. A subsequent intravenous dosing study demonstrated that in beagle dogs, DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs. This effect occurred in dogs at doses producing peak DDCT plasma levels of 810 to 3,250 nM (39 to 155 times the mean steady state DDCT plasma level measured at the maximum recommended human daily dose of

    60 mg). In dogs, peak DDCT plasma concentrations are approximately equal to peak CT plasma concentrations, whereas in humans, steady state DDCT plasma concentrations are less than 10% of steady state CT plasma concentrations. Assays of DDCT plasma concentrations in 2,020 citalopram-treated individuals demonstrated that DDCT levels rarely exceeded 70 nM; the highest measured level of DDCT in human overdose was 138 nM. While DDCT is ordinarily present in humans at lower levels than in dogs, it is unknown whether there are individuals who may achieve higher DDCT levels. The possibility that DCT, a principal metabolite in humans, may prolong the QT interval in dogs has not been directly examined because DCT is rapidly converted to DDCT in that species.

    Rev: 06/12

    Medication Guide

    Elopram (Citalopram Hydrochloride) Tablets, USP

    Read the Medication Guide that comes with Elopram (Citalopram Hydrochloride) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

    What is the most important information I should know about Elopram (Citalopram Hydrochloride) tablets?

    Elopram (Citalopram Hydrochloride) and other antidepressant medicines may cause serious side effects, including:

    1. Suicidal thoughts or actions:

    • Elopram (Citalopram Hydrochloride) and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
    • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
    • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when Elopram (Citalopram Hydrochloride) is started or when the dose is changed.

    Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

    • attempts to commit suicide
    • acting on dangerous impulses
    • acting aggressive or violent
    • thoughts about suicide or dying
    • new or worse depression
    • new or worse anxiety or panic attacks
    • feeling agitated, restless, angry or irritable
    • trouble sleeping
    • an increase in activity or talking more than what is normal for you
    • other unusual changes in behavior or mood

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Elopram (Citalopram Hydrochloride) may be associated with these serious side effects:

    2. Changes in the electrical activity of your heart (QT prolongation and Torsade de Pointes).

    This condition can be life threatening. The symptoms may include:

    • chest pain
    • fast or slow heartbeat
    • shortness of breath
    • dizziness or fainting

    3. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

    • agitation, hallucinations, coma or other changes in mental status
    • coordination problems or muscle twitching (overactive reflexes)
    • racing heartbeat, high or low blood pressure
    • sweating or fever
    • nausea, vomiting, or diarrhea
    • muscle rigidity

    4. Severe allergic reactions:

    • trouble breathing
    • swelling of the face, tongue, eyes or mouth
    • rash, itchy welts (hives) or blisters, alone or with fever or joint pain

    5. Abnormal bleeding: Elopram (Citalopram Hydrochloride) tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

    6. Seizures or convulsions

    7. Manic episodes:

    • greatly increased energy
    • severe trouble sleeping
    • racing thoughts
    • reckless behavior
    • excessive happiness or irritability
    • talking more or faster than usual

    8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

    9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.

    • headache
    • weakness or feeling unsteady
    • confusion, problems concentrating or thinking or memory problems

    Do not stop Elopram (Citalopram Hydrochloride) without first talking to your healthcare provider. Stopping Elopram (Citalopram Hydrochloride) too quickly may cause serious symptoms including:

    • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
    • headache, sweating, nausea, dizziness
    • electric shock-like sensations, shaking, confusion

    What is Elopram (Citalopram Hydrochloride)?

    Elopram (Citalopram Hydrochloride) is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Elopram (Citalopram Hydrochloride) is also used to treat:

    • Major Depressive Disorder (MDD)

      Talk to your healthcare provider if you do not think that your condition is getting better with Elopram (Citalopram Hydrochloride) treatment.

      Who should not take Elopram (Citalopram Hydrochloride)?

      Do not take Elopram (Citalopram Hydrochloride) if you:

    • are allergic to Elopram (Citalopram Hydrochloride) hydrobromide or escitalopram oxalate or any of the ingredients in Elopram (Citalopram Hydrochloride). See the end of this Medication Guide for a complete list of ingredients in Elopram (Citalopram Hydrochloride).
    • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
      • Do not take an MAOI within 14 days of stopping Elopram (Citalopram Hydrochloride).
      • Do not start Elopram (Citalopram Hydrochloride) if you stopped taking an MAOI in the last 14 days.

    People who take Elopram (Citalopram Hydrochloride) close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

    • high fever
    • uncontrolled muscle spasms
    • stiff muscles
    • rapid changes in heart rate or blood pressure
    • confusion
    • loss of consciousness (pass out)
    • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems
    • have a heart problem including congenital long QT syndrome

    What should I tell my healthcare provider before taking Elopram (Citalopram Hydrochloride) tablets? Ask if you are not sure.

    Before starting Elopram (Citalopram Hydrochloride) tablets, tell your healthcare provider if you

    • Are taking certain drugs such as:
      • Medicines for heart problems
      • Medicines that lower your potassium or magnesium levels in your body
      • Cimetidine
      • Triptans used to treat migraine headache
      • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics
      • Tramadol
      • Over-the-counter supplements such as tryptophan or St. John’s Wort
    • have liver problems
    • have kidney problems
    • have heart problems
    • have or had seizures or convulsions
    • have bipolar disorder or mania
    • have low sodium levels in your blood
    • have a history of a stroke
    • have high blood pressure
    • have or had bleeding problems
    • are pregnant or plan to become pregnant. It is not known if Elopram (Citalopram Hydrochloride) will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
    • are breast-feeding or plan to breast-feed. Some Elopram (Citalopram Hydrochloride) may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Elopram (Citalopram Hydrochloride) tablets.

    Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Elopram (Citalopram Hydrochloride) and some medicines may interact with each other, may not work as well, or may cause serious side effects.

    Your healthcare provider or pharmacist can tell you if it is safe to take Elopram (Citalopram Hydrochloride) tablets with your other medicines. Do not start or stop any medicine while taking Elopram (Citalopram Hydrochloride) tablets without talking to your healthcare provider first.

    If you take Elopram tabletsm you should not take any other medicones that contain citalipram hydrobromide or escitalopram oxalate including Lexapro®

    How should I take Elopram (Citalopram Hydrochloride)?

    • Take Elopram (Citalopram Hydrochloride) tablets exactly as prescribed. Your healthcare provider may need to change the dose of Elopram (Citalopram Hydrochloride) tablets until it is the right dose for you.
    • Elopram (Citalopram Hydrochloride) tablets may be taken with or without food.
    • If you miss a dose of Elopram (Citalopram Hydrochloride) tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Elopram (Citalopram Hydrochloride) tablets at the same time.
    • If you take too much Elopram (Citalopram Hydrochloride) tablets, call your healthcare provider or poison
    • control center right away, or get emergency treatment.

    What should I avoid while taking Elopram (Citalopram Hydrochloride) tablets?

    Elopram (Citalopram Hydrochloride) tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Elopram (Citalopram Hydrochloride) tablets affects you. Do not drink alcohol while using Elopram (Citalopram Hydrochloride) tablets.

    What are the possible side effects of Elopram (Citalopram Hydrochloride) tablets?

    Elopram (Citalopram Hydrochloride) may cause serious side effects, including:

    See “What is the most important information I should know about Elopram (Citalopram Hydrochloride) tablets?”

    Common possible side effects in people who take Elopram (Citalopram Hydrochloride) tablets include:

    • Nausea
    • Sleepiness
    • Weakness
    • Dizziness
    • Feeling anxious
    • Trouble sleeping
    • Sexual problems
    • Sweating
    • Shaking
    • Not feeling hungry
    • Dry mouth
    • Constipation
    • Diarrhea
    • Respiratory Infections
    • Yawning

    Other side effects in children and adolescents include:

    • increased thirst
    • abnormal increase in muscle movement or agitation
    • nose bleed
    • urinating more often
    • heavy menstrual periods
    • possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with Elopram (Citalopram Hydrochloride).

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Elopram (Citalopram Hydrochloride) tablets. For more information, ask your healthcare provider or pharmacist.

    CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1800-FDA-1088.

    How should I store Elopram (Citalopram Hydrochloride) tablets?

    • Store Elopram (Citalopram Hydrochloride) at 20°C to 25°C (68°F to 77°F).
    • Keep Elopram (Citalopram Hydrochloride) bottle closed tightly.

    Keep Elopram (Citalopram Hydrochloride) tablets and all medicines out of the reach of children.

    General information about Elopram (Citalopram Hydrochloride) tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Elopram (Citalopram Hydrochloride) tablets for a condition for which it was not prescribed. Do not give Elopram (Citalopram Hydrochloride) tablets to other people, even if they have the same condition. It may harm them.

    This Medication Guide summarizes the most important information about Elopram (Citalopram Hydrochloride) tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Elopram (Citalopram Hydrochloride) that is written for healthcare professionals.

    For more information about Elopram (Citalopram Hydrochloride) tablets Camber Pharmaceutical, Inc at 1-866-495-8330 or go to www.camberpharma.com.

    What are the ingredients in Elopram (Citalopram Hydrochloride) tablets, USP?

    Active ingredient: Elopram (Citalopram Hydrochloride) hydrobromide

    Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/ Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coating agents in the beige (10 mg), pink (20 mg) and white (40 mg) tablets.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    All brand names listed are the registered trademarks of their respective owners and are not trademarks of Camber Pharmaceuticals, Inc.

    Manufactured by:

    InvaGen Pharmaceuticals, Inc.

    Hauppauge, NY 11788

    Manufactured for:

    Camber Pharmaceuticals, Inc.

    Piscataway, NJ 08854

    Rev: 02/12

    Barcode: 208-06-2012

    Elopram pharmaceutical active ingredients containing related brand and generic drugs:

    Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


    Elopram available forms, composition, doses:

    Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
    Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
    Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


    Elopram destination | category:

    Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
    Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


    Elopram Anatomical Therapeutic Chemical codes:

    A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


    Elopram pharmaceutical companies:

    Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
    Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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    References

    1. Dailymed."CITALOPRAM HYDROBROMIDE SOLUTION [SILARX PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. "citalopram". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
    3. "citalopram". http://www.drugbank.ca/drugs/DB0021... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Elopram?

    Depending on the reaction of the Elopram after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Elopram not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

    Is Elopram addictive or habit forming?

    Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

    Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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    Review

    sdrugs.com conducted a study on Elopram, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Elopram consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

    Visitor reports

    Two visitors reported useful

    How is the drug Elopram useful in reducing or relieving the symptoms? How useful is it?
    According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
    Visitors%
    Useful2
    100.0%

    Visitor reported side effects

    No survey data has been collected yet

    One visitor reported price estimates

    What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
    The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Elopram is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
    Visitors%
    Expensive1
    100.0%

    Two visitors reported frequency of use

    How often in a day do you take the medicine?
    Are you taking the Elopram drug as prescribed by the doctor?

    Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Elopram is mentioned below.
    Visitors%
    Once in a day2
    100.0%

    Ten visitors reported doses

    What is the dose of Elopram drug you are taking?
    According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 6-10mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
    Visitors%
    6-10mg5
    50.0%
    1-5mg3
    30.0%
    11-50mg2
    20.0%

    Four visitors reported time for results

    What is the time duration Elopram drug must be taken for it to be effective or for it to reduce the symptoms?
    Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 month to notice the result from using Elopram drug. The time needed to show improvement in health condition after using the medicine Elopram need not be same for all the users. It varies based on other factors.
    Visitors%
    3 month2
    50.0%
    1 day1
    25.0%
    > 3 month1
    25.0%

    Two visitors reported administration

    The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Elopram drug, before food or after food?
    Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
    Visitors%
    After food1
    50.0%
    Before food1
    50.0%

    Nine visitors reported age

    Visitors%
    16-295
    55.6%
    30-452
    22.2%
    46-601
    11.1%
    > 601
    11.1%

    Visitor reviews


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    The information was verified by Dr. Rachana Salvi, MD Pharmacology

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